Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

Congenital Heart Disease Clinical Trial

Official title:

Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484886
• Other study ID #: 38569
• Status: Completed
• Phase: N/A
• First received: November 12, 2011
• Last updated: September 4, 2014
• Start date: January 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Months

Eligibility

Inclusion Criteria:

• children </= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.

Exclusion Criteria:

• presence of a known bleeding disorder or coagulopathy.

• age > 6 months,

• lack of informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Impaired Oxygen Delivery

Intervention

Other:
• Red blood cell transfusion
10cc/kg weight RBC transfusion as needed according to hemoglobin level
• Red blood cell transfusion
10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen utilization derived from the arterio-venous oxygen difference.	Arterial and venous oxygen saturations will be measured every four hours x 48-72 hours and will be used to calculate arterio-venous oxygen content differences.	3 days	Yes
Secondary	volume of RBC transfused	The total numbers of RBC transfusions given during the immediate post-op period (1st 7 days) will be compared between groups.	7 days	Yes